Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Electrical Stimulation (BTL-5000 series, United Kingdom); Device: placebo

• Registration Number: NCT02019082
• Lead Sponsor: giti torkaman

Brief Summary

This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.

Detailed Description

Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) and skin temperature were measured at 1st, 6th, and 12th session.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2013-10-09
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-23
• Last Update Submitted: 2013-12-23
• Study First Posted: 2013-12-24
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Wagner classification DFU 2;
• age 40-60 years;
• mild to moderate diabetic neuropathy;
• ABI>0.7
• wound surface area>1.5cm2

Exclusion Criteria

• fracture in a lower limb,
• a severe infection,
• a malignancy,
• kidney failure,
• skin diseases,
• osteomyelitis,
• pregnancy,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electrical stimulation	Electrical Stimulation (BTL-5000 series, United Kingdom)	electrical stimulation group, group who received direct current ES at sensory threshold intensity for 1 h/day, 3 days/week, for 4 weeks (12 sessions)
placebo	placebo	In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero.

Primary Outcome Measures

Name	Time	Method
The plasma level of VEGF(pg/ml) and NO (microM)	prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later

Secondary Outcome Measures

Name	Time	Method
Wound surface area(cm2)	on day 1, 12, and 26
skin temperature (degree of centigrade)	prior the 12th electrical stimulation session (day 26) and 1 hour later

Trial Locations

Locations (1)

Physical Therapy Department, Faculty of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of